FDA issues guidance on off-label drug use

December 6, 2007

FDA may allow distribution of off-label use information.

The FDA has issued an internal draft guidance that would allow drug manufacturers and medical device companies to use journal articles to promote off-label use of their products without prior FDA review and approval. The chairman of the House Committee on Oversight and Government Reform, Henry A. Waxman (D, Calif.), called the guidance "ill advised" and said the change could improperly influence doctors' prescribing habits and companies would be less likely to conduct clinical trials or seek FDA approval if they knew they could promote off-label uses for their products. As outlined in the draft, manufacturers could distribute reprints of peer-reviewed research from reputable medical journals as long as they were not written or influenced by companies or individuals with financial ties to the drug or device. A draft guidance is not legally enforceable, but instead describes the FDA's current thinking on a topic and makes recommendations. The draft guidance can be accessed at http://oversight.house.gov/documents/20071130103225.pdf. To see more Daily News articles, click here. To go to the Drug Topics homepage, click here.